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A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of screening for osteoporosis in older women for the prevention of fractures

Condition category

Musculoskeletal Diseases

Date applied

14/05/2007

Date assigned

19/06/2007

Last edited

15/02/2018

Prospective/Retrospective

Retrospectively registered

Overall trial status

Completed

Recruitment status

No longer recruiting

Plain English Summary

Background and study aimsOsteoporosis is a condition that weakens the bones, making them fragile and more likely to break (fracture). Osteoporotic fractures – in particular hip fractures – have major adverse effects on quality of life in terms of pain and disability. Around 50% of hip fracture patients lose the ability to live independently and 20% die within a year of their fracture. The aim of this study is to investigate whether a community-based screening programme for osteoporosis reduces the incidence of fractures, and is cost effective, in older women (aged 70 - 85 years).

Who can participate? Women aged 70 to 85 who are not currently on prescription medication to prevent osteoporotic fractures.

What does the study involve? Participants are randomly allocated to either the screening group or the control group. Those in the screening group have their risk of fracture calculated using data from a questionnaire and, for some participants, results from a DXA (x-ray) scan. Participants above an age-dependent threshold are recommended for treatment (typically bisphosphonate tablets), and to continue treatment for the duration of the study. The risk of fracture is not calculated for participants in the control group, who receive usual care. Participants are followed-up 6 months later and then annually by postal questionnaires and checking of medical records. The proportion of participants sustaining fractures is measured for each group, along with hip fracture rate. Cost-effectiveness is also assessed, as well as the acceptability of the DXA scanning and risk assessment process.

What are the possible benefits and risks of participating? Participants in the screening group have the opportunity to discuss treatment with their GP that would reduce their fracture risk. In addition, everyone taking part in the study will be helping to determine whether screening would be beneficial in older women. Taking part in this study will involve some time to complete questionnaires. If a participant in the screening group is invited to have a DXA bone density scan this would involve a single appointment lasting about 15 to 30 minutes with the DXA provider (usually at an NHS hospital trust). The DXA scanner uses much less radiation than a normal x-ray, such as a chest x-ray, and is equivalent to a few days of natural background radiation.

Where is the study run from? University of East Anglia (UK)

When is the study starting and how long is it expected to run for? February 2007 to December 2015

Who is funding the study? 1. Medical Research Council (MRC) (UK)2. Arthritis Research Campaign (UK)

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of Screening for Osteoporosis in Older women for the Prevention of fractures (SCOOP)

Acronym

SCOOP

Study hypothesis

To investigate whether a community-based screening programme for osteoporosis reduces the incidence of fractures, and is cost effective, in older women (aged 70 - 85 years).

Ethics approval

The North West Research Ethics Committee, 20/09/2007

Study design

Two-group pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Musculoskeletal Diseases: Osteoporosis

Intervention

Intervention subjects will have a 10-year absolute risk of fracture calculated from a World Health Organization (WHO) risk algorithm based on data from a screening questionnaire and, for some subjects, results from a Dual energy X-ray Absorptiometry (DXA) scan. GPs will be advised of those at high risk and whether to consider treatment.

The control group will have usual care.

Both intervention and control groups will be provided with lifestyle advice through an Arthritis Research Campaign (ARC) booklet on osteoporosis.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

All osteoporosis-related fractures (excluding those of hands, feet, nose and skull), assessed at the annual follow-up visits for 5 years post randomisation.

Secondary outcome measures

1. All clinical fractures (including hip fractures)2. Quality of life, assessed by the European Quality of life (EQ-5D) and Short Form 12 (SF-12) questionnaires at baseline (immediately prior to randomisation), 6 and 12 months and then annually for 5 years post randomisation3. Psychological anxiety, assessed by the State-Trait Anxiety Index at baseline, 6 and 12 months and then annually for 5 years post randomisation4. Mortality (assessed annually for 5 years post randomisation)

A process measure will be treatment adherence as ascertained by an ad-hoc questionnaire at follow-up visits.

Overall trial start date

01/02/2007

Overall trial end date

30/12/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Female2. Aged 70 to 85 years3. Able to provide informed consent

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

11,580

Participant exclusion criteria

1. Currently known to be on treatment for osteoporosis (other than calcium and vitamin D)2. Any known co-morbidity that would make entry to the trial inadvisable, in GP's opinion

Recruitment start date

01/02/2007

Recruitment end date

01/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of East Anglia
Norwich
NR4 7TJ
United Kingdom

Trial participating centre

University of Birmingham
B15 2TH
United Kingdom

Trial participating centre

University of Bristol
BS2 8DZ
United Kingdom

Trial participating centre

University of Manchester
M13 9PT
United Kingdom

Trial participating centre

University of Sheffield
S57 7AU
United Kingdom

Trial participating centre

University of Southampton
SO16 6YD
United Kingdom

Trial participating centre

University of York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of East Anglia (UK)

Sponsor details

Research Enterprise & Engagement University of East Anglia Norwich NR4 7TJ United Kingdom
-H.Ings@uea.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Arthritis Research Campaign (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date.

IPD sharing statementThe trialists plan to make data available on request, subject to terms of data sharing agreement drawn up by University of East Anglia.

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/02/2018: Internal review.
19/12/2017: Publication references added
08/03/2016: The overall trial end date was changed from 30/06/2015 to 30/12/2015.
02/10/2014: The overall trial end date was changed from 30/04/2014 to 30/06/2015.